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Clinical Trials/NCT00772200
NCT00772200
Active, Not Recruiting
N/A

Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer

Children's Oncology Group184 sites in 1 country1,200 target enrollmentFebruary 27, 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Childhood Malignant Neoplasm
Sponsor
Children's Oncology Group
Enrollment
1200
Locations
184
Primary Endpoint
Compliance rate for completion of neuropsychological and behavioral battery
Status
Active, Not Recruiting
Last Updated
7 months ago

Overview

Brief Summary

This research trial studies neuropsychological (learning, remembering or thinking) and behavioral outcomes in children and adolescents with cancer by collecting information over time from a series of tests.

Detailed Description

PRIMARY OBJECTIVES: I. To institute procedures to ensure a consistent, streamlined, and efficient administration of the neuropsychological/behavioral tests in a cooperative group setting in order to maximize compliance with a standardized assessment battery conducted at 3 standardized time points. OUTLINE: Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery at approximately 9, 30, and 60 months post-diagnosis in a 1-2 hour testing session conducted by a neuropsychologist or psychologist. The Battery consists of measures of intelligence, processing speed, attention, memory, language preference, behavioral/social/emotional function, executive function, adaptive function, and quality of life.

Registry
clinicaltrials.gov
Start Date
February 27, 2009
End Date
TBD
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The patient must be currently be enrolled or plan to be enrolled on a COG therapeutic study that aims to examine neuropsychological, social, emotional, and/or behavioral functioning
  • The patient must have receptive and expressive language skills in English, French, or Spanish; if a patient meets these criteria but the parent/guardian speaks a language other than English, French, or Spanish, the patient may still be enrolled and tested, and the parent-report measures should be omitted
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria

  • Patients with a history of moderate to profound intellectual disability (i.e. intelligence quotient \[IQ\] =\< 55) are not eligible for enrollment; PLEASE NOTE: Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g., dyslexia) are eligible for this study

Outcomes

Primary Outcomes

Compliance rate for completion of neuropsychological and behavioral battery

Time Frame: Up to 72 months post-diagnosis

Study Sites (184)

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